Status:
COMPLETED
Convalescent Plasma for Treatment of COVID-19 Patients With Pneumonia
Lead Sponsor:
University of Virginia
Conditions:
Corona Virus Infection
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without c...
Detailed Description
There are no proven treatments for coronavirus disease (COVID-19) and associated pneumonia caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Recent experience in China suggests t...
Eligibility Criteria
Inclusion
- Patients must be 18 years of age or older
- Patients hospitalized with COVID-19 respiratory symptoms within 72 hours of admission to a"floor" bed (non-ICU bed) and confirmation via SARS-CoV-2 RT-PCR testing.
- Patient and/or surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
- Patients with hematologic malignancies or solid tumors are eligible.
- Patients with autoimmune disorders are eligible.
- Patients with immunodeficiency and organ or stem cell transplant recipients are eligible.
- Patients who have received or are receiving hydroxychloroquine or chloroquine are eligible (but will be taken off the drug)
- Prior use of IVIG is allowed but the investigator should consider the potential for a hypercoagulable state.
Exclusion
- Patients requiring mechanical ventilation or \>6 liters per minute nasal cannula oxygen
- Patients on other anti-COVID-19 trials being treated with tocilizumab (anti-IL-6 receptor), Siltuximab (anti-IL-2), Remdesivir, or other pharmacological trials that may be initiated hereafter.
- A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy).
- Contraindication to transfusion or history of prior reactions to transfusion blood products.
- Medical conditions for which receipt of 500-600 mL of intravenous fluid may be dangerous to the subject (e.g., decompensated congestive heart failure).
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04374565
Start Date
May 5 2020
End Date
March 5 2021
Last Update
April 1 2022
Active Locations (2)
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1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
2
University of Virginia
Charlottesville, Virginia, United States, 22903